A US company claims to have received federal approval to market a 9-mm handgun as a medical device and hopes the US government will reimburse seniors who buy the &dollar;300 firearm. But the US Food and Drug Administration says there are currently no formal designations of the gun as a medical device.

Called the Palm Pistol, the weapon is designed for people who have trouble firing a normal handgun due to arthritis and other debilitating conditions.

“It’s something that they need to assist them in daily living,” says Matthew Carmel, president of Constitution Arms in Maplewood, New Jersey, which hopes to manufacture the Palm Pistol – now just a patent and specifications.

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“The justification for this would be no more or less for a [walking aid] or wheelchair, or any number of things that are medical devices,” he says.

The sales information reads&colon; “It is also ideal for seniors, disabled or others who may have limited strength or manual dexterity. Using the thumb instead of the index finger for firing, it significantly reduces muzzle drift, one of the principal causes of inaccurate targeting. Point and shoot couldn’t be easier.”

Constitutional Arms informed a medical technology blog that the FDA had approved the Palm Pistol as a medical device, classifying it as a “Daily Activity Assist Device”.

The company reportedly said that they are now seeking a Durable Medical Equipment coding for the gun, which if awarded would allow it to be prescribed and reimbursement paid through Medicare or private health insurance.

Health benefits?

But FDA spokeswoman Siobhan DeLancey denies that the agency has formally labelled the gun a medical device&colon; “At this time, there have been no formal designations of the Palm Pistol by the FDA as a medical device.”

“The FDA doesn’t make a determination about a weapon, they make a determination about medical products that are designed to help people and improve their health,” says Bill Maisel, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.

Carmel contends that he submitted documentation to the FDA to get Palm Pistol listed as a Class I medical device – a classification reserved for devices that pose little risk to a patient’s health, such as stethoscopes and walking aids.

Registration doubts

As evidence of the government’s stamp of approval, Carmel points to a notice (pdf format) he received from FDA.

Dated 2 December 2008, it reads&colon; “You have successfully entered your facility registration and device listing information,” then goes onto list an address in Maplewood, New Jersey, for Constitution Arms.

“I see that a facility has been registered. That does not register a device or a pistol,” Maisel says.

Even if the FDA were to approve the Palm Pistol as a medical device, securing Medicare reimbursement is another issue entirely, says Kevin Schulman, an expert on medical device regulation at Duke University Medical Center in Durham, North Carolina. “Medicare does not cover everything that FDA approves.”

‘Nice gimmick’

To reimburse a drug, treatment or device, Medicare must determine that it is reasonable and necessary in the course of medical treatment, he says. “The first question for Medicare is whether this would be potentially beneficial, and the answer seems to be obviously no.”

Constitution Arms is taking pre-orders for the Palm Pistol, while Carmel determines whether the market is large enough to go into production. “I’ve been getting a lot of calls,” he says.

For &dollar;25, customers can be one of the first to own the weapon, which Carmel expects to deliver by 2010. The refundable deposit will sit in an escrow account and serve as proof to investors that the Palm Pistol has a sizeable market, he says.

The potential for Medicare reimbursement, and perhaps even payment from private insurers will also encourage investors.

“It’s not implanted in the body, but the obvious result of this thing [a bullet] could be,” says Schulman.

“It’s a nice gimmick for this manufacturer, but I can’t imagine that Medicare would pay for this, since it doesn’t meet their criteria,” he says. “They’re trying to game the system, clearly, but hopefully they won’t get much further.”